Exact FDA event identifier

Event 72308

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: September 25, 2015
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Actavis Laboratories, FL, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.

D-0014-2016

Recall number: D-0014-2016
Initiated: September 25, 2015
Classification: Class II
Status: Terminated
Recalling firm: Actavis Laboratories, FL, Inc.
Quantity: 13,284 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.

Code information

Lot: 1037736A, Exp 03/18

Distribution pattern

Nationwide and Puerto Rico